EP3579908B1 - Gaines orientables pouvant être soumises à un couple - Google Patents

Gaines orientables pouvant être soumises à un couple Download PDF

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Publication number
EP3579908B1
EP3579908B1 EP18722365.6A EP18722365A EP3579908B1 EP 3579908 B1 EP3579908 B1 EP 3579908B1 EP 18722365 A EP18722365 A EP 18722365A EP 3579908 B1 EP3579908 B1 EP 3579908B1
Authority
EP
European Patent Office
Prior art keywords
inner liner
deflectable portion
pull wire
distal end
proximal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP18722365.6A
Other languages
German (de)
English (en)
Other versions
EP3579908A1 (fr
Inventor
Troy Tegg
Bruce Ebner
Cherry Knight
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
St Jude Medical Cardiology Division Inc
Original Assignee
St Jude Medical Cardiology Division Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by St Jude Medical Cardiology Division Inc filed Critical St Jude Medical Cardiology Division Inc
Publication of EP3579908A1 publication Critical patent/EP3579908A1/fr
Application granted granted Critical
Publication of EP3579908B1 publication Critical patent/EP3579908B1/fr
Active legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A61M2025/015—Details of the distal fixation of the movable mechanical means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor

Definitions

  • the present disclosure relates to steerable introducers and methods of making steerable introducers. More particularly, the present invention relates to the torqueable steerable sheaths for steerable introducers and methods of making such sheaths.
  • Steerable introducers are often used for the delivery of medical devices, such as catheters, to a target site.
  • the sheath of the steerable introducer is manipulated through the patient's vasculature and to the intended site, for example, a site within the patient's heart or other organ, with a medical device, such as a catheter, within a lumen of the sheath.
  • the medical device, or a portion thereof, is advanced out of the sheath for use at the target site.
  • Steerable sheaths for steerable introducers are typically steered by use of pull wires embedded in the sheath on opposite sides of the sheath.
  • the pull wires extend parallel to each other in a straight line from a proximal end of the sheath near the handle of the steerable introducer to a distal end of the sheath.
  • the pull wires are fixedly coupled to the sheath at the distal end of the sheath. Pulling one of the pull wires toward the proximal end of the sheath shortens that pull wire causing a deflectable portion of the distal end of the sheath to deflect in the direction of the shortened wire.
  • steerable sheaths are known from WO 94/14494 A2 , US 2016/001038 A1 , US 2016/374541 A1 and WO 2017/062514 A1 .
  • the present disclosure is directed to a steerable sheath having a proximal end and a distal end.
  • the steerable sheath includes an inner liner having an outer circumference and extending from the proximal end to the distal end of the steerable sheath.
  • the inner liner includes a non-deflectable portion having a proximal end and a distal end, the non-deflectable portion extending from the proximal end of the steerable sheath toward the distal end of the steerable sheath.
  • the inner liner also includes a deflectable portion extending the proximal end adjacent the distal end of the non-deflectable portion to a distal end at the distal end of the steerable sheath.
  • the steerable sheath includes a first pull wire positioned along a first helical path around the circumference of the inner liner from the proximal end to the distal end of the non-deflectable portion of the inner liner and along a first straight path from the proximal end of the deflectable portion to the distal end of the deflectable portion.
  • the steerable sheath includes a second pull wire positioned along a second helical path around the circumference of the inner liner from the proximal end to the distal end of the non-deflectable portion and along a second straight path from the proximal end of the deflectable portion to the distal end of the deflectable portion.
  • the present disclosure is also directed to a steerable introducer including a handle assembly and the above-described steerable sheath.
  • the present disclosure is further directed to a method of producing a steerable sheath.
  • the method includes positioning first pull wire along a first helical path around a circumference of a non-deflectable portion of an inner liner from a proximal end of the non-deflectable portion of the inner liner to a distal end of the non-deflectable portion of the inner liner and positioning first pull wire along a first straight path from a proximal end of a deflectable portion of the inner liner to a distal end of the deflectable portion, wherein the proximal end of the deflectable portion of the inner liner is adjacent the distal end of the non-deflectable portion of the inner liner.
  • the method further includes positioning a second pull wire along a second helical path around the circumference of the non-deflectable portion of the inner liner from the proximal end of the non-deflectable portion of the inner liner to the distal end of the non-deflectable portion of the inner liner and positioning the second pull wire along a second straight path from the proximal end of the deflectable portion of the inner liner to the distal end of the deflectable portion of the inner liner.
  • Steerable introducers may include pull wires extending along a length of the introducer's steerable sheath from a proximal end of the sheath to a distal end of the sheath.
  • proximal refers to a direction toward the end of the introducer or sheath near the clinician
  • distal refers to a direction away from the clinician and (generally) inside the body of a patient.
  • the pull wires are positioned on opposite sides of the steerable sheath and each runs in a generally straight line from the proximal end to the distal end of the steerable sheath.
  • one of the pull wires is shortened (e.g., pulled toward the proximal end of the steerable introducer) to place it under tension to cause a deflectable portion at the distal end of the steerable sheath to deflect in the direction of the tensioned pull wire. If the operator applies a torque to the introducer to cause the sheath to rotate along its central axis when one of the pull wires is under tension, the pull wires are rotated around the deflected portion of the sheath.
  • the pull wire that is not under tension will need to shorten as it is rotated from an outside of the deflected portion (e.g., from an outer radius of a curve) to an inside of the deflected portion (e.g., to an inner radius of the curve) or the deflected portion of the sheath will change its deflection.
  • the tensioned pull wire needs to lengthen as it is rotated by the torque from the inside of the deflected portion to the outside of the deflected portion to maintain the same deflection of the sheath.
  • energy is stored in the pull wires as the rotation of the sheath attempts to force them to change their lengths.
  • This stored energy may release suddenly, causing the distal end of the steerable sheath to make a sudden, fast, and unpredictable movement, sometimes referred to as whipping. At other times, the stored energy may cause one or both of the pull wires to break, typically at their anchor points within the handle of the steerable introducer.
  • the present disclosure is directed to a steerable sheath including pull wires configured to permit the application of torque to the introducer with the steerable sheath in a deflected position while reducing the likelihood of breaking the pull wires and/or whipping of the distal end of the steerable sheath.
  • the systems and methods described herein provide a steerable sheath having pull wires that are wrapped around the circumference of the steerable sheath as they extend along the length of a non-deflectable portion of the steerable sheath.
  • the pull wires are disposed in a non-overlapping, helical pattern from the proximal end of the sheath to the distal end of the non-deflectable section of the sheath.
  • the pull wires are disposed in straight lines on opposite sides of the sheath from the proximal end of the deflectable section to the distal end of the deflectable section.
  • the rotation of the pull wires along the length of the non-deflectable section reduces the energy stored in the pull wires when torque is applied to the steerable introducer while the deflectable section is in a deflected position. This allows a smooth, approximately one-to-one response of the steerable introducer to an applied torque without breaking the pull wires or whipping the distal end of the sheath.
  • the teachings of the present disclosure may be applied to other steerable shafts, and particularly to other steerable medical devices.
  • the pull wire arrangements described herein may be applied to steerable catheters and intracardiac echocardiography catheters.
  • FIG. 1 is a perspective view of a steerable introducer assembly 100 according to one embodiment.
  • Introducer assembly 100 includes a handle assembly 102 at a proximal end 104 and a steerable sheath 106 extending to a distal end 108 of steerable introducer assembly 100.
  • Steerable sheath 106 is operably coupled to handle assembly 102, which assists in guiding or steering steerable sheath 106 during procedures.
  • Introducer assembly 100 further includes a hub 110 operably connected to an inner lumen (not shown) within handle assembly 102 for insertion or delivery of catheter assemblies, fluids, or any other devices known to those of ordinary skill in the art.
  • introducer assembly 100 further includes a valve 112 operably connected to hub 110.
  • Steerable sheath 106 includes a flexible, non-deflectable portion 114 and a deflectable portion 116.
  • Non-deflectable portion 114 extends from handle assembly 102 to deflectable portion 116.
  • Deflectable portion 116 is configured to be controllably deflectable by an operator of introducer assembly 100 using pull wires (not shown in FIG. 1 ) extending through steerable sheath 106 from deflectable portion 116 to handle assembly 102.
  • Components within sheath 106 (discussed below) in non-deflectable portion 114 and deflectable portion 116 may also be referred to as having corresponding non-deflectable and/or deflectable portions. Additional details of the construction and operation of a handle suitable for use as handle assembly 102 are described in U.S. Patent No. 7,691,095 . In other embodiments, any other handle suitable for operating steerable sheath 106 may be used as handle assembly 102.
  • FIG. 2 is a cross-sectional view of steerable sheath 106 taken along the line A-A shown in FIG. 1 .
  • Steerable sheath 106 is comprised of a tubular inner liner 202 (also sometimes referred to as an "inner jacket"), a torque transfer layer 204, an outer sheath 206, a heat shrink layer 208, and pull wires 210.
  • the components of steerable sheath 106 may have different positions relative to each other component.
  • torque transfer layer 204 may be positioned radially inward of pull wires 210.
  • pull wires 210 are positioned directly adjacent inner liner 202.
  • Steerable sheath 106 is manufactured using a reflow bonding process. Reflow bonding processes suitable for forming steerable sheath 106 are described in U.S. Patent Nos. 7,914,515 and 8,734,699 . In other embodiments, any other suitable method for manufacturing steerable sheath 106 may be used. Heat shrink layer 208 is removed from steerable sheath 106 after a reflow process.
  • pull wires 210 are flat wires.
  • a "flat wire” refers to a wire that is characterized by a cross-section that, when measured along two orthogonal axes, is substantially flat.
  • a flat wire typically has a rectangular cross section, though the cross section need not be perfectly rectangular.
  • the present disclosure contemplates that a cross section of the flat wire may be oval, provided that the overall cross section is generally flat.
  • a wire may be properly characterized as a flat wire if it has a cross section that is measured x in one direction and at least 2x in a second direction generally orthogonal to the first direction.
  • a wire whose cross section is substantially I-shaped may also be a flat wire if, generally, its height is substantially greater than its width at its widest measurement.
  • pull wires 210 are round wires or wires of any other shape suitable for use as described herein.
  • Pull wire 210 is preferably about 0.002" by about 0.016", and more preferably about 0.004" by about 0.012" or 0.016". Pull wire 210 may be selected such that the ratio of the width to thickness is at least about 2:1.
  • pull wires 210 are stainless steel wires.
  • pull wires 210 may be made of any other suitable material, such as spring steel, Nitinol (nickel titanium alloy), or a nickel-cobalt base alloy.
  • a suitable nickel-cobalt base alloy includes MP35N®, which is a registered trademark of SPS Technologies. Inc., of Jenkintown, PA, USA.
  • pull wires 210 are encased inside another polymeric tubular member 212 forming a lumen 214 for housing the pull wire 210.
  • Polymeric tubular member 212 need not be the same shape as the cross section of pull wire 210, but instead, may be round, oval, rectangular, or another like shape.
  • polymeric tubular member 212 has a cross section that is not the same shape as a cross section of pull wire 210, in order to facilitate movement of pull wire 210 in the preformed tube.
  • two pull wires 210 are used in steerable sheath 106.
  • pull wires 210 rotate around a circumferential direction 220 of steerable sheath 106 as they extend along the non-deflectable portion 114 of steerable sheath 106.
  • pull wires 210 remain spaced at about 180 degrees apart.
  • Pull wires 210 extend in straight lines 180 degrees apart through deflectable portion 116 (shown in FIG. 1 ) without wrapping around sheath 106 in circumferential direction 220. This results in a steerable sheath 106 that can be deflected in two opposite directions by coordinated manipulation of the pull wires 210.
  • four pull wires located 90 degrees apart may be used to provide four directions of deflectability.
  • any suitable number of pull wires may be used to provide a desired number of deflection directions for steerable sheath 106.
  • a method of attaching polymeric tubular member 212 to inner liner 202 is depicted.
  • adhesive 802 is applied at a plurality of adhesive locations 804.
  • Polymeric tubular member 212 is coupled to inner liner 202 by compressing polymeric tubular member 212 against adhesive 802.
  • Such an attachment method is labor-intensive and, in some cases, may not result in complete coupling of polymeric tubular member 212 to inner liner 202.
  • such an attachment method increases in complexity when polymeric tubular members 212 are attached to inner liner 202 in a helical arrangement to accommodate the helical path of pull wires 210.
  • polymeric tubular member 212 is instead attached to inner liner 202 using a hot air component, indicated generally at 902.
  • polymeric tubular member 212 includes in inner layer 904 and an outer layer 906 surrounding inner layer 904.
  • inner layer 904 is preferably polytetrafluoroethylene (PTFE) or etched PTFE
  • outer layer 906 is preferably a thermoplastic elastomer, such as Pebax® made by Arkema, Inc.
  • Hot air component 902 is configured to apply hot air to polymeric tubular member 212, thereby melting outer layer 906.
  • the melted outer layer 906 acts as adhesive to bond polymeric tubular member 212 to inner liner 202.
  • the entirety of outer layer 906 may be melted to ensure bonding of polymeric tubular member 212 to inner liner 202 across an entire length of polymeric tubular member 212.
  • inner layer 904 preferably has a higher melting point than outer sheath 206 so that inner layer 904 will not melt when hot air component 902 applies heat thereto, nor when steerable sheath 106 is subjected to reflow melt processing.
  • lumen 214 is not formed using polymeric tubular member 212. Rather, pull wires 210 may be covered with lubricious materials (not shown) before placement, including silicone and other lubricious materials, and lumen 214 may be formed by the presence of pull wires 210 during the reflow process.
  • Pull wires 210 are connected to at least one steering ring (not shown in FIG. 2 ) typically located near the distal end 108 (shown in FIG. 1 ) of steerable introducer assembly 100.
  • the proximal ends of pull wires 210 are operably connected to a steering mechanism (not shown) in handle assembly 102 allowing for manipulation, or steering, of steerable sheath 106 during use. Additional details of the construction and operation of steering rings and steering mechanisms suitable for use in steerable introducer assembly 100 are described in U.S. Patent Application Publication No. 2007/0299424 , and U.S. Patent Nos. 7,691,095 , 7,914,515 and 8,734,699 .
  • Inner liner 202 is preferably a polymeric material, such as polytetrafluoroethylene (PTFE) or etched PTFE. Inner liner 202 may also be made of other melt processing polymers, including, without limitation, polyether block amides, nylon and other thermoplastic elastomers, such as Pebax. Pebax of various durometers may also be used, including without limitation, Pebax 30D to Pebax 70D. In a preferred embodiment, inner liner 202 is made of a material with a melting temperature higher than outer sheath 206 such that inner liner 202 will withstand the melt processing of the outer sheath 206.
  • PTFE polytetrafluoroethylene
  • Inner liner 202 may also be made of other melt processing polymers, including, without limitation, polyether block amides, nylon and other thermoplastic elastomers, such as Pebax. Pebax of various durometers may also be used, including without limitation, Pebax 30D to Peba
  • Inner liner 202 defines a lumen 216 therethrough for receiving an elongate medical device, such as a catheter.
  • Lumen 216 preferably has a diameter 218 of at least about 6 French (2 mm), more preferably of at least about 7 French (2,33 mm), and most preferably of between about 10 French (3,33 mm) and about 24 French (8 mm).
  • lumen 216 may have a diameter 218 of up to about 32 French (10,67 mm) or more, such as between about 7 French (2,33 mm) and about 32 French (10,67 mm).
  • Torque transfer layer 204 is disposed between inner liner 202 and heat shrink layer 208, and more preferably between outer sheath 206 and inner liner 202.
  • Torque transfer layer 204 may be made of stainless steel (304 or 316) wire or other acceptable materials known to those of ordinary skill in the art.
  • Torque transfer layer 204 is preferably formed of a braided wire assembly comprised of flat wires, preferably stainless steel wires including, for example, high tensile stainless steel wires.
  • Torque transfer layer 204 may be formed in any number of known braid patterns, including one-over-one (involving at least two wires) or two-over-two (involving at least four wires) crossover patterns.
  • braided flat wires of at least about 0.003" thick by at least about 0.007" wide may be used.
  • the individual wires have a ratio of width to the thickness of at least about 2:1, including, for example, 2:1 to 5:1.
  • Flat wires of about 0.004" thick by about 0.012" wide and of about 0.004" thick by about 0.020" wide have also been braided with success to form torque transfer layers of superior performance.
  • Outer sheath 206 is preferably either an extruded Pebax or PTFE tubing.
  • the melt-processing polymer of outer sheath 206 occupies a plurality of voids of the wire mesh in torque transfer layer 204.
  • Outer sheath 206 may also be made of other melt processing polymers, including, without limitation, etched PTFE, polyether block amides, nylon and other thermoplastic elastomers, at varying durometers.
  • Outer sheath 206 may also comprise more than one layer, including, for example, two or more tubes of a melt processing polymer.
  • outer sheath 206 may be comprised of varying segments (not shown) differing in hardness and/or material along the length of steerable sheath 106 and being reflow bonded together. Varying the sheath composition in this manner provides the additional benefit of adjusting flexibility, torqueability, and pushability at various points along steerable sheath 106.
  • FIGS. 3 , 4 , and 5 are various views of steerable sheath 106 with torque transfer layer 204, outer sheath 206, and heat shrink layer 208 removed.
  • FIG. 3 is a side view of steerable sheath 106.
  • FIG. 4 is a top view of steerable sheath 106 in the same configuration as seen from direction 314 shown in FIG. 3 .
  • FIG. 5 is an enlarged view of a section 400 of steerable sheath 106 shown in FIG. 4 .
  • Pull wires 210 are separately identified in FIGS. 3 , 4 , and 5 as first pull wire 300 and second pull wire 302. As shown in FIG. 3 , deflectable portion 116 is deflected to a U-shape having an inner radius 304 and an outer radius 306. Pull wires 210 extend from a proximal end 310 of steerable sheath 106 to distal end 108.
  • first pull wire 300 and second pull wire 302 wrap around inner liner 202.
  • Inner liner 202 is a cylindrical tube having an outer circumference 500 (shown in FIG. 5 ).
  • first pull wire 300 and second pull wire 302 traverse around circumference 500 of inner liner 202 as they extend from proximal end 310 toward distal end 108.
  • each pull wire 210 follows a substantially helical path from proximal end 310 to distal end 108.
  • First pull wire 300 and second pull wire 302 both wrap around inner liner 202 at a same rate (e.g., number of rotations per unit of length) and do not cross over each other.
  • first pull wire 300 is offset from the helical path followed by second pull wire by 180 degrees around the circumference 500 (i.e., in a circumferential direction) of inner liner 202.
  • first pull wire 300 and second pull wire 302 remain substantially 180 degrees apart throughout non-deflectable portion 114.
  • first pull wire 300 and second pull wire 302 are each wrapped twice (i.e., 720 degrees or two revolutions) around inner liner 202 as they traverse non-deflectable portion 114 from proximal end 310 toward distal end 108.
  • pull wires 300, 302 may wrap around inner liner 202 a different number of times. As the number of revolutions about inner liner 202 increases, torqueability of steerable sheath 106 without whipping or breaking pull wires 210 generally increases. However, friction along pull wires 210 may also increase with increased revolutions, leading to greater force being necessary to deflect deflectable portion 116.
  • each pull wire 210 makes between one and four revolutions around inner liner 202 in non-deflectable portion 114. In some embodiments, each pull wire 210 makes between one and three revolutions around inner liner 202 in non-deflectable portion 114. In some embodiments, each pull wire 210 makes between one and two revolutions around inner liner 202.
  • first pull wire 300 and second pull wire 302 may be bonded to inner liner 202 to hold them in place until the reflow process is performed.
  • polymeric tubular member 212 to form lumen 214 both shown in FIG. 2
  • polymeric tubular member 212 may be bonded to inner liner 202.
  • first pull wire 300 and second pull wire 302 are wrapped around inner liner 202 in a counter-clockwise manner (as viewed from proximal end 310). In other embodiments, first pull wire 300 and second pull wire 302 wrap around inner liner 202 in a clockwise manner (as viewed from proximal end 310).
  • first pull wire 300 and second pull wire 302 do not wrap around inner liner 202. Rather, first pull wire 300 and second pull wire 302 each traverse a substantially straight path from a proximal end 312 of deflectable portion 116 to distal end 108. Although not visible in FIG. 3 , first pull wire 300 continues from proximal end 312 of deflectable portion 116 to distal end 108 along outer radius 306. Similarly, second pull wire 302 continues from proximal end 312 of deflectable portion 116 to distal end 108 along inner radius 304. In FIG. 4 , first pull wire 300 can be seen traversing a straight path along a portion of outer radius 306 in deflectable portion 116.
  • first pull wire 300 and second pull wire 302 are illustrated as ending at proximal end 310, it should be understood that first pull wire 300 and second pull wire 302 may extend beyond inner liner 202 in the proximal direction to permit access (such as by handle assembly 102, shown in FIG. 1 ) to first pull wire 300 and second pull wire 302 for operation of steerable sheath 106.
  • FIG. 6 is a cross-section of another embodiment of a steerable sheath 602 of steerable introducer assembly 100 (shown in FIG. 1 ). Specifically, a distal portion 604 of steerable sheath 602 is shown. Steerable sheath 602 may be substantially similar to steerable sheath 106 (shown in FIG. 1 ). In the illustrated embodiment, steerable sheath 602 includes a shaft 606 circumscribing a pull ring or steering ring 608 coupled to at least one pull wire 210. Although only one pull wire 210 is illustrated in the view of FIG.
  • steerable sheath 602 may include two pull wires 210 in a helical arrangement along at least a portion of sheath 602 and/or in a straight line along at least a portion of sheath 602, about 180 degree apart.
  • a distal tip 610 of shaft 606 is relatively soft or low-durometer, to minimize the risk of tissue damage upon impact of distal tip 610 with any tissue in a patient's vasculature.
  • an intermediate segment 612 of distal portion 604 provided around pull ring 608 is relatively hard or high-durometer.
  • tension in pull wire 210 is increased to deflect at least a portion of shaft 606, a relatively high load is experienced at intermediate segment 612 provided around pull ring 608. Accordingly, increasing the hardness of intermediate segment 612 facilitates intermediate segment 612 withstanding these increased loads.
  • a body segment 614 of shaft 606 is relatively flexible to allow flexion thereof.
  • Body segment 614 may extend from a deflectable portion (e.g., deflectable portion 116, shown in FIG. 1 ) to a non-deflectable portion (e.g., non-deflectable portion 114, also shown in FIG. 1 ) of steerable sheath 602, from distal portion 604 to a proximal end (not shown) of steerable sheath 602, or along any suitable portion of steerable sheath 602.
  • a deflectable portion e.g., deflectable portion 116, shown in FIG. 1
  • a non-deflectable portion e.g., non-deflectable portion 114, also shown in FIG. 1
  • FIG. 7A illustrates an arrangement of pull ring 608 coupled to pull wire 210, as also shown in FIG. 6 .
  • Pull ring 608 has a proximal face 702 oriented towards a proximal end (not shown) of a steerable sheath (e.g., steerable sheath 106, shown in FIG. 1 , or steerable sheath 602, shown in FIG. 6 ) in which pull ring 608 is provided.
  • Pull ring 608 also has a distal face 704 opposite proximal face 702.
  • the material of the sheath may be bonded with pull ring 608.
  • proximal face 702 is substantially planar. As such, the bond between pull ring 608 and the steerable sheath in which pull ring 608 is provided limited to the planar surface area of proximal face 702.
  • pull ring 608 defines a pocket 706 in which a distal end 708 of pull wire 210 is positioned. Specifically, distal end 708 is coupled (e.g., adhered, welded, fastened, etc.) to pull ring 608 within pocket 706.
  • FIG. 7B is a cross-section of a first embodiment of a modified pull ring 608' coupled to pull wire 210.
  • Modified pull ring 608' has a proximal face 710 oriented towards a proximal end (not shown) of a steerable sheath (e.g., steerable sheath 106, shown in FIG. 1 , or steerable sheath 602, shown in FIG. 6 ) in which modified pull ring 608' is provided.
  • Proximal face 710 has an irregular or non-planar shape.
  • proximal face 710 includes a plurality of troughs or grooves 712.
  • Grooves 712 may be annular grooves, radial grooves, irregular grooves, and/or have any other shape or orientation. Grooves 712 increase the surface area of proximal face 710. Accordingly, grooves 712 increase the bond surface area when modified pull ring 608' is provided within a steerable sheath. As such, grooves 712 improves the bond strength between the steerable sheath when steerable sheath is bent. In other words, during increased loads (i.e., when pull wires 210 are pulled t deflect modified pull ring 608'), grooves 712 facilitate improved bending at a joint defined between the steerable sheath and proximal face 710 without degradation of the bond at the joint.
  • FIGS. 7C and 7D are respective cross-sections of alternative embodiments of a modified pull ring 608' coupled to a modified pull wire 210'.
  • modified pull ring 608' includes a modified pocket 714.
  • Modified pocket 714 includes one or more projections 716 that project radially into modified pocket 714.
  • modified pull wire 210' defines one or more cutouts 718 in distal end 708 thereof. Each cutout 718 receives a respective projection 716 therein.
  • modified pull ring 608' includes a modified pocket 720.
  • Modified pocket 720 defines a diameter 722 thereof that increases as modified pocket 720 extends axially inwardly into modified pull ring 608'.
  • modified pull wire 210' defines a diameter 724 thereof that increases along distal end 708 thereof.
  • Each of the modified pockets 714, 720 in combination with their respective modified pull wires 210' facilitates further strengthening the bond at the joint defined between modified pull rings 608' and the steerable sheath (e.g., steerable sheath 106, shown in FIG. 1 , or steerable sheath 602, shown in FIG. 6 ) in which the respective modified pull ring 608' is provided.
  • the modified pockets 714 and/or 720 are combined with proximal face 710 (shown in FIG. 7B ) to even further strength the bond at the pull ring-sheath interface.
  • joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the disclosure as defined in the appended claims.

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Claims (14)

  1. Gaine orientable (106, 602) ayant une extrémité proximale (310) et une extrémité distale (108), la gaine orientable (106, 602) comprenant,
    un revêtement interne (202) ayant une circonférence externe et s'étendant de l'extrémité proximale (310) à l'extrémité distale (108) de la gaine orientable (106, 602), le revêtement interne (202) comprenant :
    une partie non déformable (114) ayant une extrémité proximale et une extrémité distale, la partie non déformable (114) s'étendant de l'extrémité proximale (310) de la gaine orientable (106, 602) vers l'extrémité distale (108) de la gaine orientable (106, 602) ;
    une partie déformable (116) s'étendant d'une extrémité proximale adjacente à l'extrémité distale de la partie non déformable (114) vers une extrémité distale à l'extrémité distale (108) de la gaine orientable (106, 602) ;
    un premier fil de traction (210, 300) positionné le long d'un premier trajet hélicoïdal autour de la circonférence externe du revêtement interne (202) de l'extrémité proximale à l'extrémité distale de la partie non déformable (114) du revêtement interne (202) et le long d'un premier trajet rectiligne de l'extrémité proximale de la partie déformable (116) à l'extrémité distale de la partie déformable ;
    et
    un second fil de traction (210, 310) positionné le long d'un second trajet hélicoïdal autour de la circonférence externe du revêtement interne (202), de l'extrémité proximale à l'extrémité distale de la partie non déformable (114) et le long d'un second trajet rectiligne de l'extrémité proximale de la partie déformable (116) à l'extrémité distale de la partie déformable (116).
  2. Gaine orientable (106, 602) selon la revendication 1, dans laquelle le premier trajet hélicoïdal et le second trajet hélicoïdal effectuent chacun deux tours autour du revêtement interne (202) de l'extrémité proximale à l'extrémité distale de la partie non déformable (114).
  3. Gaine orientable (106, 602) selon la revendication 1 ou 2, dans laquelle le premier fil de traction (210, 300) et le second fil de traction (210, 300) comprennent un fil plat.
  4. Gaine orientable (106, 602) selon l'une quelconque des revendications 1 à 3, dans laquelle le premier fil de traction (210, 300) et le second fil de traction (210, 300) sont des fils de traction en acier inoxydable.
  5. Gaine orientable (106, 602) selon l'une quelconque des revendications 1 à 4, dans laquelle le trajet hélicoïdal est décalé du second trajet hélicoïdal de 180 degrés autour de la circonférence externe du revêtement interne (202).
  6. Gaine orientable (106, 602) selon l'une quelconque des revendications 1 à 5, dans laquelle le premier trajet rectiligne est décalé du second trajet rectiligne de 180 degrés autour de la circonférence externe du revêtement interne (202).
  7. Gaine orientable (106, 602) selon l'une quelconque des revendications 1 à 6, comprenant en outre un élément tubulaire polymère couplé au revêtement interne (202) pour loger le premier fil de traction (210, 300).
  8. Introducteur orientable (100) comprenant,
    un ensemble de poignées (102),
    la gaine orientable (102, 602) selon l'une quelconque des revendications 1 à 7, la gaine orientable (106, 602) étant couplée de manière opérationnelle à l'ensemble de poignée.
  9. Introducteur orientable (100) selon la revendication 8, dans lequel chacun des premier fils de traction (210, 300) et second fils de traction (210, 300) s'étend de l'extrémité proximale de la gaine orientable (106, 602) et est couplé de manière opérationnelle à l'ensemble de poignée (102).
  10. Procédé de production d'une gaine orientable (106, 602) comprenant les étapes consistant à :
    positionner un premier fil de traction (210, 300) le long d'un premier trajet hélicoïdal autour d'une circonférence d'une partie non déformable (114) d'un revêtement interne (202) d'une extrémité proximale de la partie non déformable (114) du revêtement interne (202) à une extrémité distale de la partie non déformable (114) du revêtement interne (202) ;
    positionner le premier fil de traction (210, 300) le long d'un premier trajet rectiligne d'une extrémité proximale d'une partie déformable (116) du revêtement interne (202) à une extrémité distale de la partie déformable (116), dans lequel l'extrémité proximale de la partie déformable (116) du revêtement interne (202) est adjacente à l'extrémité distale de la partie non déformable (114) du revêtement interne (202) ;
    positionner un second fil de traction (210, 310) le long d'un second trajet hélicoïdal autour de la circonférence de la partie non déformable (114) du revêtement interne (202), de l'extrémité proximale de la partie non déformable (114) du revêtement interne (202) à l'extrémité distale de la partie non déformable (114) du revêtement interne (202) ; et
    positionner le second fil de traction (210, 310) le long d'un second trajet rectiligne de l'extrémité proximale de la partie déformable (116) du revêtement interne (202) à l'extrémité distale de la partie déformable (116) du revêtement interne (202).
  11. Procédé selon la revendication 10, dans lequel le positionnement du premier fil de traction (210, 300) le long du premier trajet hélicoïdal comprend le positionnement du premier fil de traction (210, 300) le long d'un premier trajet hélicoïdal qui effectue deux tours autour de la circonférence du revêtement interne (202) entre une extrémité proximale de la partie non déformable (114) et l'extrémité distale de la partie non déformable (114), et le positionnement du second fil de traction (210, 310) le long du second trajet hélicoïdal comprend le positionnement du second fil de traction (210, 310) le long d'un second trajet hélicoïdal qui effectue deux tours autour de la circonférence du revêtement interne (202) entre une extrémité proximale de la partie non déformable (114) et l'extrémité distale de la partie non déformable (114).
  12. Procédé selon la revendication 10 ou 11, dans lequel le positionnement du second fil de traction (210, 310) le long du second trajet hélicoïdal comprend le positionnement du second fil de traction (210, 310) le long d'un second trajet hélicoïdal décalé du premier trajet hélicoïdal de 180 degrés dans une direction circonférentielle autour du revêtement interne (202).
  13. Procédé selon l'une quelconque des revendications 10 à 12, comprenant en outre les étapes consistant à :
    coller un premier élément tubulaire polymère (212) sur le revêtement interne (202) en appliquant de l'air chaud sur le premier élément tubulaire polymère (212) ;
    lier un second élément tubulaire polymère (212) au revêtement interne (202) en appliquant de l'air chaud au second élément tubulaire polymère (212) ;
    positionner le premier fil de traction (210, 300) dans le premier élément tubulaire polymère (212) ; et
    positionner le second fil de traction (210, 310) dans le second élément tubulaire polymère (212).
  14. Procédé selon l'une quelconque des revendications 10 à 13, dans lequel le positionnement du second fil de traction (210, 310) le long du second trajet rectiligne comprend le positionnement du second fil de traction (210, 310) le long d'un second trajet rectiligne décalé du premier trajet rectiligne de 180 degrés dans une direction circonférentielle autour du revêtement interne (202).
EP18722365.6A 2017-04-18 2018-04-18 Gaines orientables pouvant être soumises à un couple Active EP3579908B1 (fr)

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US11918762B2 (en) 2018-10-03 2024-03-05 St. Jude Medical, Cardiology Division, Inc. Reduced actuation force electrophysiology catheter handle

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US11484690B2 (en) 2022-11-01
CN110545874B (zh) 2021-09-17
CN110545874A (zh) 2019-12-06
US20180296801A1 (en) 2018-10-18
EP3579908A1 (fr) 2019-12-18
WO2018195162A1 (fr) 2018-10-25
JP2020516412A (ja) 2020-06-11
JP6936872B2 (ja) 2021-09-22

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